Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration.

This article presents the CONSORT (consolidated standards of reporting trials) extension for cluster randomised crossover trials. A cluster randomised crossover trial involves randomisation of groups of individuals (known as clusters) to different sequences of interventions over time. The design has gained popularity in settings where cluster randomisation is required because it can largely overcome the loss in power due to clustering in parallel cluster trials.

Exposure to adversity and inflammatory outcomes in mid and late childhood.

Background: We aimed to estimate the association between exposure to adversity and inflammatory markers in mid (4 years) and late (11-12 years) childhood, and whether effects differ by type and timing of exposure.

Methods: : Barwon Infant Study (BIS; N = 510 analyzed) and Longitudinal Study of Australian Children (LSAC; N = 1156 analyzed). : Adversity indicators assessed from 0 to 4 (BIS) and 0-11 years (LSAC): parent legal problems, mental illness and substance abuse, anger in parenting responses, separation/divorce, unsafe neighborhood, and family member death; a count of adversities; and, in LSAC only, early (0-3), middle (4-7), or later (10-11) initial exposure.

Modest decrease in severity of obesity in adolescence associates with low arterial stiffness.

Background And Aims: Childhood obesity is associated with cardiovascular risk factors (CVRF), subclinical cardiovascular phenotypes (carotid intima-media thickness, cIMT; pulse-wave velocity, PWV; and carotid elasticity), and adult cardiovascular disease (CVD) mortality. In youth with obesity (body mass index, BMI ≥95th centile), we investigated associations between changes in adiposity and CVRF in early adolescence and subclinical cardiovascular phenotypes in late adolescence.

Methods: Participants had adiposity measures (the severity of obesity in percentage >95th BMI-centile (%>95th BMI-centile)), waist circumference (WC), percentage total body fat (%BF) and CVRF (systolic blood pressure, SBP; glycoprotein acetyls, GlycA; and low-density lipoprotein cholesterol) assessed in early (mean age 10.

Natural history of mental health competence from childhood to adolescence.

Background: Mental health competence (MHC) involves psychosocial capabilities such as regulating emotions, interacting well with peers and caring for others, and predicts a range of health and social outcomes. This study examines the course of MHC from childhood to adolescence and patterning by gender and disadvantage, in Australian and UK contexts.

Methods: Longitudinal Study of Australian Children (n=4983) and the Millennium Cohort Study (n=18 296).

Enrollment challenges in multicenter, international studies: The example of the GAS trial.

Introduction: Randomized trials are important for generating high-quality evidence, but are perceived as difficult to perform in the pediatric population. Thus far there has been poor characterization of the barriers to conducting trials involving children, and the variation in these barriers between countries remains undescribed. The General Anesthesia compared to Spinal anesthesia (GAS) trial, conducted in seven countries between 2007 and 2013, provides an opportunity to explore these issues.

Sample size calculations for cluster randomised crossover trials in Australian and New Zealand intensive care research.

Objective: The cluster randomised crossover (CRXO) design provides an opportunity to conduct randomised controlled trials to evaluate low risk interventions in the intensive care setting. Our aim is to provide a tutorial on how to perform a sample size calculation for a CRXO trial, focusing on the meaning of the elements required for the calculations, with application to intensive care trials.

Data Sources: We use all-cause in-hospital mortality from the Australian and New Zealand Intensive Care Society Adult Patient Database clinical registry to illustrate the sample size calculations.

Intellectual disability in cerebral palsy: a population-based retrospective study.

Aim: A population-based observational study design was used to describe the epidemiology of intellectual disability in cerebral palsy (CP) in terms of clinical and neuroimaging associations, and to report the impact of intellectual disability on utilization of health services and length of survival.

Method: Population CP registry data were used to retrospectively assess the frequency of intellectual disability and strength of associations between intellectual disability and mobility, epilepsy, vision, hearing, communication, and neuroimaging patterns (n=1141). Data linkage was undertaken to assess usage of hospital inpatient and emergency department services.

Surgical practice and outcome in 711 neonates and infants undergoing hernia repair in a large multicenter RCT: Secondary results from the GAS Study.

Background: The GAS study is an international RCT to evaluate neurodevelopmental outcome comparing general plus regional anesthesia versus regional anesthesia alone in 722 neonates and infants who had inguinal hernia repair up to 60 weeks of postmenstrual age. This paper comprises a secondary descriptive analysis of hernias, aspects of surgery and outcomes.

Methods: The incidence of unilateral and bilateral hernias, side preponderance, predictive factors for bilateral hernias and surgical approaches were collated.

Intrathecal baclofen therapy in children: an analysis of individualized goals.

Aim: To determine whether intrathecal baclofen (ITB) therapy improves performance and performance satisfaction in goal areas identified by patients' parents.

Method: This study formed part of an ongoing multicentre national audit involving six paediatric ITB pump implant centres across Australia. The Canadian Occupational Performance Measure was the primary outcome measure utilized at baseline, 6 months, and 12 months after pump implants in paediatric patients receiving ITB therapy for the first time between 31st December 2009 and 31st December 2014.

Understanding the cluster randomised crossover design: a graphical illustraton of the components of variation and a sample size tutorial.

Background: In a cluster randomised crossover (CRXO) design, a sequence of interventions is assigned to a group, or 'cluster' of individuals. Each cluster receives each intervention in a separate period of time, forming 'cluster-periods'. Sample size calculations for CRXO trials need to account for both the cluster randomisation and crossover aspects of the design.

Sleep problems in the first year of elementary school: The role of sleep hygiene, gender and socioeconomic status.

Objectives: To determine (1) the relationship between sleep hygiene practices and parent-reported child sleep problems in students in the first year of elementary school, (2) whether the relationship differed by (a) gender and (b) SES and (3) in a multivariate explanatory model.

Design: Cross-sectional survey of a population-based sample.

Setting: Forty-five elementary schools in metropolitan Melbourne, Australia.

The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality.

Background: The cluster randomised crossover (CRXO) design is gaining popularity in trial settings where individual randomisation or parallel group cluster randomisation is not feasible or practical. Our aim is to stimulate discussion on the content of a reporting guideline for CRXO trials and to assess the reporting quality of published CRXO trials.

Methods: We undertook a systematic review of CRXO trials.

Characterising the ambient sound environment for infants in intensive care wards.

Aim: The purpose of this study is to characterise ambient sound levels of paediatric and neonatal intensive care units in an old and new hospital according to current standards.

Methods: The sound environment was surveyed for 24-h data collection periods (n = 80) in the Neonatal and Paediatric Intensive Care Units (NICUs and PICUs) and Special Care Nursery of the old and new Royal Children's Hospital Melbourne. The ambient sound environment was characterised as the proportion of time the ongoing ambient sound met standard benchmarks, the mean 5-s sound levels and the number and duration of noise events.

Appropriate statistical methods were infrequently used in cluster-randomized crossover trials.

Objective: To assess the design and statistical methods used in cluster-randomized crossover (CRXO) trials.

Study Design And Setting: We undertook a systematic review of CRXO trials. Searches of MEDLINE, EMBASE, and CINAHL Plus; and citation searches of CRXO methodological articles were conducted to December 2014.

Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.

Background: Preclinical data suggest that general anaesthetics affect brain development. There is mixed evidence from cohort studies that young children exposed to anaesthesia can have an increased risk of poor neurodevelopmental outcome. We aimed to establish whether general anaesthesia in infancy has any effect on neurodevelopmental outcome.

Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial.

Background: Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia (GA) on neurodevelopment.

Predictors of Failure of Awake Regional Anesthesia for Neonatal Hernia Repair: Data from the General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes.

Background: Awake regional anesthesia (RA) is a viable alternative to general anesthesia (GA) for infants undergoing lower abdominal surgery. Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes. The General Anesthesia compared to Spinal anesthesia study compares neurodevelopmental outcomes after awake RA or GA in otherwise healthy infants.

140 mmol/L of sodium versus 77 mmol/L of sodium in maintenance intravenous fluid therapy for children in hospital (PIMS): a randomised controlled double-blind trial.

Background: Use of hypotonic intravenous fluid to maintain hydration in children in hospital has been associated with hyponatraemia, leading to neurological morbidity and mortality. We aimed to assess whether use of fluid solutions with a higher sodium concentration reduced the risk of hyponatraemia compared with use of hypotonic solutions.

Methods: We did a randomised controlled double-blind trial of children admitted to The Royal Children's Hospital (Melbourne, VIC, Australia) who needed intravenous maintenance hydration for 6 h or longer.

The use of the cluster randomized crossover design in clinical trials: protocol for a systematic review.

Background: The cluster randomized crossover (CRXO) design is gaining popularity in trial settings where individual randomization or parallel group cluster randomization is not feasible or practical. In a CRXO trial, not only are clusters of individuals rather than individuals themselves randomized to trial arms, but also each cluster participates in each arm of the trial at least once in separate periods of time.We will review publications of clinical trials undertaken in humans that have used the CRXO design.

Shared care obesity management in 3-10 year old children: 12 month outcomes of HopSCOTCH randomised trial.

Objective: To determine whether general practice surveillance for childhood obesity, followed by obesity management across primary and tertiary care settings using a shared care model, improves body mass index and related outcomes in obese children aged 3-10 years.

Design: Randomised controlled trial.

Setting: 22 family practices (35 participating general practitioners) and a tertiary weight management service (three paediatricians, two dietitians) in Melbourne, Australia.

How does the introduction of a pain and sedation management guideline in the paediatric intensive care impact on clinical practice? A comparison of audits pre and post guideline introduction.

Unlabelled: Despite the use of guidelines to inform practice for pain and sedation management there are few evaluations of the effect of their introduction on clinical practice. Previous evaluations of the protocols and guidelines used to manage pain and sedation in the paediatric intensive care unit (PICU) report increases in pain and sedation medication administration post guideline introduction. In most reported cases the guideline was accompanied by a treatment algorithm.